Could citrus flavonoids boost chemo for rectal cancer? new trial launches
NCT ID NCT07176182
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a citrus flavonoid tablet (Aimailang) to standard chemotherapy (mFOLFOX) before surgery can shrink tumors more effectively in people with locally advanced rectal cancer that has a specific marker (YWHAB). About 236 participants will be randomly assigned to receive chemo alone or chemo plus the tablet for 4-6 cycles before surgery. The main goal is to see how many patients have their tumor stage reduced to a lower risk level after treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 236 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Histopathologically confirmed rectal adenocarcinoma; all other histologic subtypes are excluded. Presence of hemorrhoids confirmed by colonoscopy or clinical physical examination. 2. Radiographically measurable or clinically evaluable rectal tumor lesion; clinical pathologic stage T2N+ or T3-4aAnyN, M0. Clinical staging is determined by physical examination, contrast-enhanced chest and abdominopelvic CT, and pelvic MRI. For patients with MRI contraindications, staging is performed with contrast-enhanced pelvic CT plus transrectal ultrasound. Staging adheres to the 9th AJCC TNM Staging System (Appendix 1). 3. Pelvic MRI confirms the tumor is not adherent to the mesorectal fascia (MRF-negative), defined as a tumor-MRF distance ≥ 2 mm (tumor distance \< 2 mm is defined as MRF involvement). 4. ectal cancer tumor specimens demonstrate high YWHAB expression by immunohistochemistry. 5. Age 18-75 years at the time of informed consent. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 3). 7. No prior systemic anticancer therapy for rectal cancer, including cytotoxic chemotherapy, immune checkpoint inhibitors, molecular targeted agents, or endocrine therapy. 8. Adequate organ function with screening laboratory parameters meeting the following criteria: * White blood cell count ≥ 3 × 10⁹/L * Absolute neutrophil count ≥ 1.5 × 10⁹/L * Platelet count ≥ 75 × 10⁹/L * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN * Serum creatinine ≤ 1.5 × ULN 9. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to initiation of study treatment and agree to use a highly effective, medically acceptable contraceptive method (e.g., intrauterine device, combined oral contraceptives, barrier methods) throughout the study and for 3 months after the last study drug administration. 10. Male patients with partners of childbearing potential must practice effective contraception during the study and for 3 months following the last study drug administration. 11. The patient voluntarily provides written informed consent and is willing and able to comply with all scheduled study visits, treatment administration, laboratory assessments, and protocol-specified procedures.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Sixth Affiliated Hospital of Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510655, China
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Other studies related to the condition(s) this trial covers.
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